Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma
- Conditions
- MelanomaUnresectable Melanoma
- Registration Number
- NCT05428007
- Lead Sponsor
- NYU Langone Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Patients must have signed and dated an Institutional Review Board/Independent Ethics<br> Committee -approved written informed consent form in accordance with regulatory and<br> institutional guidelines. This must be obtained before the performance of any<br> protocol-related procedures that are not part of normal patient care<br><br> - Patients must be willing and able to comply with scheduled visits, treatment<br> schedule, laboratory tests, tumor biopsies, and other requirements of the study.<br><br> - All patients must be either Stage IIIb/c/d or Stage IV according to the American<br> Joint Committee on Cancer (AJCC) (8th edition) and have histologically-confirmed<br> melanoma that is felt to be surgically unresectable in order to be eligible. Please<br> refer to the AJCC Cancer Staging Manual, 8th edition for a description of tumor,<br> lymph node, metastasis and staging.<br><br> - All melanomas, except ocular/uveal melanoma, regardless of primary site of<br> disease will be allowed; mucosal melanomas are eligible.<br><br> - Patients must not have received prior anticancer treatment for metastatic<br> disease (for example, but not limited to, systemic, local, radiation,<br> radiopharmaceutical).<br><br>oExceptions: Surgery for melanoma and/or post-resection brain radiotherapy (RT) if<br>central nervous system (CNS) metastases and local radiation for locoregional disease<br>and/or prior treatment with adjuvant nivolumab, dabrafenib and trametinib, pembrolizumab,<br>interferon (IFN) or ipilimumab (IPI) (as described in Exclusion Criterion 8,4 full<br>protocol below).<br><br> - All patients must have their disease status documented by a complete physical<br> examination and imaging studies within 4 weeks prior to the first dose of study<br> drug. Imaging studies must include computerized tomography (CT) scan of chest,<br> abdomen, pelvis, and all known sites of resected disease in the setting of Stage<br> IIIb/c/d or Stage IV disease, and brain magnetic resonance imaging ([MRI]; brain CT<br> is allowable if MRI is contraindicated).<br><br> - Disease must be measurable by RECIST 1.1<br><br> - The complete set of baseline radiographic images must be available before treatment<br> initiation.<br><br>Exclusion Criteria:<br><br> - Patients with untreated brain metastases, carcinomatosis meningitis or current<br> ocular/uveal melanoma are excluded.<br><br> - Patients with previous non-melanoma malignancies are excluded unless a complete<br> resection or remission was achieved at least 2 years prior to study entry and no<br> additional therapy is required or anticipated to be required during the study period<br> (exceptions include, but are not limited to, non-melanoma skin cancers, in situ<br> bladder cancer, in situ gastric cancer or gastrointestinal stromal tumor, in situ<br> colon cancers, in situ cervical cancers/dysplasia, or breast carcinoma in situ).<br><br> - Patients with active, known, or suspected autoimmune disease. Patients with type I<br> diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only<br> requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or<br> alopecia) not requiring systemic treatment are permitted to enroll. For any cases of<br> uncertainty, it is recommended that the Principal Investigator be consulted prior to<br> signing informed consent.<br><br> - Patients with a condition requiring systemic treatment with either corticosteroids<br> (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications<br> within 14 days of study drug administration. Inhaled or topical steroids are<br> permitted in the absence of active autoimmune disease
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Grades 3-5 Treatment-Related Immune-Related Adverse Events (irAE) per NCI CTCAE v 5.0 Criteria;Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Category
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS);Overall survival (OS);Best overall response (iBOR);Disease Control Rate (DCR);Duration of Overall Response;Duration of disease control;Immune-related Response Rate (irRR) per irRC criteria;Immune-related Response Rate (irRR) per irRC criteria;Immune-related Disease Control Rate per irRC criteria;Immune-related Progression-Free Survival (irPFS);Duration of Immune-related Overall Response;Duration of Immune-related Disease Control